Health Condition 1: null- HIV 1 INFECTION
Conditions
Interventions
Intervention1: Tab. Dolutegravir 50 mg: Integrase Inhibitor
Control Intervention1: Not applicable: Not applicable
Sponsors
Emcure Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: HIV 1 infected Subjects Willing and able to understand and provide signed and dated written informed consent after screening. 18 years or older, and adults with weight more than 40 kgs. HIV-1 positive Subjects who are either. ART naïve Treatment experienced with NRTIâ??s, NNRTIâ??s , PI and Raltegravir based regimen with Viral load less than 50 copies/ml Subjects with ART failure having Viral load more than 50 copies/ml General medical condition does not interfere with trial procedures Females are eligible if: They do not plan to become pregnant during the study and next 18 months after baseline Negative screening pregnancy test and uses one of the following methods: Abstinence from penile/vaginal intercourse during the study Double contraceptive methods of which one must be barrier (condom).
Exclusion criteria
Exclusion criteria: Known hypersensitivity to any of the Anti-retrovirals drugs or components of Dolutegravir based regimen. Pulmonary tuberculosis and or Extrapulmonary tuberculosis on treatment. Creatinine clearance less than 30mL per min determined using Cockcroft and Gault formula. Hepatic impairment of Child Pugh B C. Treatment with Radiation therapy, cancer chemotherapy or immunomodulator within 28 days of Screening. Any preexisting psychiatric conditions: depression, bipolar disorders, schizophrenia. Pregnant and Lactating HIV-1 infected subjects. Unwilling to give consent for audio recording and unwilling to participate in the study. Any other Contraindications of the other antiretroviral drugs to be used as backbone therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Incidence rate of AE_ADVERSE EVENTS_ by system organ class and severity Frequency and severity of AE_ Clinical and Lab abnormalities Intention to treat analysis Tolerability Number of subjects who discontinue the study treatment due to AE Assessed by comparing AE profile among subjects given twice daily vs single dose of dolutegravir and among those with advanced immunosuppression Analysis of time to discontinuation of antiretroviral regimen due to any AE Timepoint: Causality of AE and SAE would be assessed by using Naranjo Scale and WHO-UMC Causality Categories and assessment criteria. Univariable and multivariable analysis would be done to explore risk factors for the development of AE and SAE at 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| effectiveness as measured trends in change of viral load Timepoint: 12 and 24 | — |
Countries
India
Contacts
Public ContactDr Abhijit Vasantrao Kadam
ICMR-National AIDS Research Institute
Outcome results
None listed